WO2016072107A1 - Medical device - Google Patents

Medical device Download PDF

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Publication number
WO2016072107A1
WO2016072107A1 PCT/JP2015/065888 JP2015065888W WO2016072107A1 WO 2016072107 A1 WO2016072107 A1 WO 2016072107A1 JP 2015065888 W JP2015065888 W JP 2015065888W WO 2016072107 A1 WO2016072107 A1 WO 2016072107A1
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WO
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Application
Patent type
Prior art keywords
portion
drive shaft
cutting
struts
shaft
Prior art date
Application number
PCT/JP2015/065888
Other languages
French (fr)
Japanese (ja)
Inventor
八田知紀
小林淳一
中野泰佳
Original Assignee
テルモ株式会社
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A61B19/54
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2/013Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stending
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320716Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320733Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320775Morcellators, impeller or propeller like means
    • A61B2019/5466
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/016Filters implantable into blood vessels made from wire-like elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/018Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting

Abstract

Provided are: a medical device which is capable of expanding inside a lumen of a living organism, and which is capable of cutting an object from the inner wall surface of the lumen of the living organism, while reducing the burden on the living organism and damage to the device; and a treatment method. This medical device (10) for cutting an object inside a lumen of a living organism is provided with: a rotatable drive shaft (60); a strut (41) which is rotatably coupled to the distal side of the drive shaft (60), extends along the rotational axis (X), and has a central section capable of expanding outwards in the radial direction; and a support part (50) which is rotatably coupled to the distal side of the drive shaft (60), is provided with a plurality of gaps, is formed so as to be mesh-like and tubular, has at least one section positioned inside the strut (41) in the radial direction, and is capable of expanding outwards in the radial direction as a result of a central section thereof in the direction along the rotational axis (X) being bent.

Description

The medical device

The present invention relates to medical devices for cutting the object from the inner wall surface of a living body lumen.

A method of treating stenosis due plaque and thrombus of a coronary artery, percutaneous transluminal coronary angioplasty to expand the blood vessel by a balloon (PTCA) or a reticulated or coiled stent and a method of placement in a blood vessel as a support for the vessel and the like. However, these methods, or if the plaque narrowing portion is hard and calcified, if occurring at the branch portion of the coronary artery, it is difficult to apply. As a method capable of treating even in such a case, there is atherectomy cutting the constriction of such plaque or thrombus.

As a device for atherectomy, for example, Patent Document 1, the outer surface of the rotary member at the tip portion of the catheter adhere diamond particles (abrasive), the rotary member is rotated in the coronary arteries, stenosis was It describes a device for cutting. Rotation of the device is provided with four bars arranged in the circumferential direction, by projecting by bending the bar radially outward, to fit the vessel diameter has become extensible.

JP-T 2003-504090 JP

As the device described in Patent Document 1, when a possible expansion and shrinkage bars, since the bar edges are in contact with the blood vessel, large damage risk to normal vessels, further as calcified plaque when cutting such a hard stenosis was that hard stenotic material bar gap is sandwiched, the device may be damaged is high.

The present invention has been made to solve the problems described above, while facilitating the transportation of the body lumen can also ensure proper cutting range, it is possible to reduce the burden on the biological tissue, and device damage and to provide a medical device capable of suppressing.

Medical device according to the present invention for achieving the above object is a medical device for cutting an object of a living body lumen, a rotatable drive shaft, rotatably coupled to a distal side of the drive shaft , and the at least one strut can be extended radially outward by the central portion is deflected with extending along the rotation axis is rotatable coupled to a distal side of the drive shaft, a plurality support portion at least partially formed in a net-like and tubular provided with a gap located radially inwardly of said struts, and is extensible in the central portion in the direction along the rotary shaft is bent radially outward and, with a.

Medical devices constructed as described above, since the struts can be extended, by extension, while facilitating the transportation of the body lumen can ensure proper cutting range. Furthermore, the medical device, the support portion, because the supporting struts from the radially inner side, while reducing excessive damage to biological tissue by the edge of the strut, that an object is sandwiched in the gap of the strut the device of damage or breakage can be suppressed by suppressing.

The struts, when the object to distal position than sites most extended radially outward in the expanded state so as blades for cutting is formed, safe and hardly contacts the blade body tissue while ensuring sex, the blade by pressing the strut to the stenosis in contact to the object of the body lumen, it is possible to cut the object effectively.

Maximum extension of the most extended radially outward of the supporting portion in the expanded state, from between the struts to protrude radially outward from the struts is less impact on the biological tissue than the struts the maximum extension of the support portion is in contact with the living tissue, it is possible to suppress damage to normal biological tissue by the edge of the strut, it is possible to increase the safety.

The struts in the expanded state, the outer peripheral surface of the site where the blade is formed, if so inclined as the rotational direction radially inward, the contact from the side that is inclined radially inwardly of the strut target to smooth contact with, it can be reduced excessive damage to biological tissue by struts.

The strut has a relatively wide wide portion than to the region where the width in the rotation direction are adjacent, projecting of if so that the blade to the wide portion is formed, radially outward of the supporting portion There is inhibited by the wide portion can be good contact blades without being inhibited by the support portion to be contacted.

Length maximum extension protrudes from the strut radially outward, the support portion from between said struts at a site where the wide part is arranged diameter of the most expanded radially outward of the supporting portion in the expanded state if so greater than the length which projects outwardly, the maximum extension in contact with the biological tissue while suppressing damage to the normal region by struts, effectively a blade strut to the object of the body lumen it can be satisfactorily cut the object in contact.

The struts, when to have an inclined portion inclined with respect to the rotation axis in the contracted state, in the expanded state, the asymmetry of the shape of the inclined portion, so as to be inclined to a desired angle to the outer circumferential surface of the strut It can be set, the degree of freedom in design is improved. Therefore, struts and damage to biological tissues hardly occurs, and it is possible to set the cutting easily angle the object body lumen.

At least one of the struts and the support part, if such is covered by the hydrophilic material, between at least one and the living tissue of the cutting portion and the support portion is slippery, to suppress excessive damage to living tissue it is possible to enhance the safety Te.

Wherein drive shaft a tube, wherein the medical device is movable in the axial direction relative to the drive shaft is arranged inside the drive shaft, and rotatable together with the drive shaft linear further comprising a shaft, said support portion is extensible receives a force in the axial direction by the movement of the relative axial of the drive shaft and linear motion shaft radially outward, the struts, the distal side or proximal side, the not constrained movement in the axial direction relative to the drive shaft and linear motion shaft, the strut is extended by being pressed radially outward by the expansion of the radially outer side of the supporting part it may be configured. Thus, when expanding the strut, hardly a gap between the strut and the support part, hardly caught an object such as a stenosis substances and debris between the strut and the support portion. Therefore, the medical device can suppress damage to the strut, and can suppress damage to the normal biological tissue by the edge of the strut.

Wherein the drive shaft is a tube body, wherein the medical device is movable in the axial direction relative to the drive shaft is arranged inside the drive shaft, and rotatable together with the drive shaft linear a shaft, a tubular body which is arranged inside the drive shaft, and the inner tube which rotate relative to the drive shaft and linear motion shaft unconstrained, may be configured to further include a. Thus, the medical device, even if the drive shaft and linear motion shaft rotates, the inner tube does not rotate, the rotational force is not exerted on the wire or the like which is inserted into the inner tube. Therefore, the medical device, to suppress the wear of the wire or the like that is inserted into the inner tube, and can be suppressed wire or the like becomes difficult pulling it rotates. Further, since the inner tube does not rotate, not easily pulled blood into the lumen of the inner tube, thus suppressing the occurrence of blood coagulation in the lumen, it is possible to suppress the deterioration of the operability. Moreover, the medical device, since the inner pipe which wire or the like is inserted does not rotate, and prevented from moving by receiving the frictional force from the inner tube wire or the like in the axial direction, can suppress damage to the blood vessels.

The medical device, a portion of the strut or support section may be configured to have a contrast portion consisting of X-ray contrast material. Thus, it is possible to accurately grasp the position and expanded diameter of strut or support section under X-ray fluoroscopy, the procedure is made more easily.

The medical device, the distal side of the strut, a plurality of convex portions on the outer circumferential surface a tubular is formed, and may be configured to further include a rotatable tip tube together with the drive shaft. Thus, also enables cutting the stenosis by the tip tube, quickly cutting the stenosis.

Cutting portion of the medical device according to the first embodiment is a plan view showing a state in which contracted. Is a plan view showing a state where the cutting unit of the treatment device is expanded. Is a plan view showing a distal portion of the treatment device, (A) a state in which the cutting unit is accommodated in the outer sheath, (B) a state in which the cutting unit contracted protrudes from the outer sheath, (C) an outer sheath It shows a state in which the cutting portion is extended projecting from. It is a longitudinal sectional view showing a distal portion of the treatment device. It is a sectional view taken along the line A-A of FIG. 3 (B). Is a diagram showing a treatment device in the expanded state, is a cross-sectional view taken along (A) is a sectional view taken along the line B-B in FIG. 3 (C), the line C-C in (B) Figure 3 (C) . It is a plan view showing a filter device. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) the state when inserting the guide wire into a blood vessel, a state where the insertion (B) is a guiding catheter into a blood vessel show. It is a schematic sectional view showing a state in the blood vessel when performing a procedure, showing a state in which the insertion (A) the state when inserting the support catheter to the stenosis, (B) is a filter device into a blood vessel . It is a schematic sectional view showing a state in the blood vessel when performing a procedure, showing a state in which the insertion (A) the state when allowed to expand a filter unit, (B) is a treatment device into a blood vessel. Is a schematic sectional view showing a state in the blood vessel when performing procedure was (A) is a state at the time of exposing the cutting portion and the support portion of the treatment device, (B) is to expand the cutting portion and the support portion indicate the status of the case. Is a schematic sectional view showing a state in the blood vessel when performing a procedure, shows the (A) state at the time of cutting the stenotic material by treatment device, (B) a state which accommodates a cutting portion to the outer sheath. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) is a debris trapped in the filter unit status at the time of suction by a catheter, (B) inside the tube a filter portion showing the accommodated state. Cutting portion of the medical device according to the second embodiment is a plan view showing a state in which contracted. It is a longitudinal sectional view showing a distal portion of a medical device according to the second embodiment. It is a longitudinal sectional view showing a proximal portion of the treatment device according to the second embodiment. Is a plan view showing the drive shaft in the second embodiment. It is a plan view showing another example of the drive shaft in the second embodiment. Is a sectional view taken along line E-E in FIG. 16. It is a longitudinal sectional view showing a treatment device in the second embodiment, before (A) is the tip tube contacts the cutting section is shown after contact with (B) at a tip tube cutting unit. It is a longitudinal sectional view showing a liquid supply unit in the second embodiment. It is a longitudinal sectional view showing a distal portion of the treatment device of the second embodiment when primed. It is a longitudinal sectional view showing a proximal portion of the treatment device of the second embodiment when primed. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) the state when inserting the treatment device into a blood vessel, (B) is when exposing the cutting portion and the support portion of the treatment device It shows the state. It is a longitudinal sectional view showing a proximal portion of the time of rotating the dial of the treatment device according to the second embodiment. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) the state when allowed to expand a cutting portion and the support portion, (B) is the time that cutting the stenosis was purified by treatment device It shows the state. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) the state when the pull-back cutting section and the support section from the constriction, (B) is at the time of cutting the stenotic material by treatment device It shows the state. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) has a cutting portion and the support unit status at the time of retraction from the stenosis, (B) is further extended cutting portion and the support portion indicate the status of the case. Is a schematic sectional view showing the state of a blood vessel in performing procedures, (A) the state when that cutting the stenosis was purified by treatment device, (B) a state at the time of cutting the stenotic material by treatment device It is shown. Is a schematic sectional view showing a state in the blood vessel when performing a procedure, showing a state at the time of receiving (A) a cutting portion while accommodated in the outer sheath, the interior (B) in the tube a filter portion . Is a plan view showing a modified example of the medical device according to the first embodiment. It is a sectional view showing another modification of the medical device according to the first embodiment. It is a longitudinal sectional view showing a modified example of the medical device according to the second embodiment. It is a plan view showing another modification of the medical device according to the second embodiment. It is a sectional view showing still another modification of the medical device according to the second embodiment.

Hereinafter, with reference to the drawings, an embodiment of the present invention. Incidentally, the dimensional ratios in the drawings, for convenience of description, may be different from the exaggerated with actual ratios.
<First Embodiment>

Medical device 10 according to the first embodiment of the present invention are used for the treatment (treatment) for cutting the stenosis or occlusion due to plaque or thrombus in a blood vessel. In this specification, the side to be inserted into a blood vessel of the device "distal", the proximal side to operate is referred to as "proximal".

Medical device 10 according to the first embodiment of the present invention, as shown in FIG. 1, a treatment device 20 for cutting the stenosis or occlusion, and falling off scraped off from the stenosis or occlusion debris to (object) a filter device 30 for trapping, and a.

Treatment device 20, as shown in FIGS. 1 and 2, the expansion and contraction can cutting portion 40 radially outward, and a support portion 50 for supporting the cutting unit 40, a drive shaft 60 for rotating the cutting portion 40 , a linear motion shaft 70 to adjust the deformation amount of the cutting portion 40, a tip tube 75 which is connected to the distal side of the translation shaft 70, the outer sheath 80 capable of accommodating the cutting portion 40, provided on the proximal side and an operation unit 90 for operating Te.

Cutting unit 40, as shown in FIGS. 3-6, the struts 41 of the at least one extending along the rotation axis X of the drive shaft 60 (four in this embodiment), at the distal side of all of the struts 41 a distal fixed end 42 of the tubular formed to struts 41 integrally, and a proximal fixed end 43 of the tubular which is formed integrally with the strut 41 at the proximal side of all of the struts 41. It struts 41, contracted state has a substantially linear shape (FIG. 3 (B), the reference to FIG. 5) from that approximate the distal fixed end 42 and a proximal fixed end 43, modified to flex radially outward to the expanded state (FIG. 3 (C), the reference to FIG. 6) may be a.

Struts 41, proximally, in contracted state is formed the inclined portion 44 which is curved so as to be inclined with respect to the rotation axis X, the distal side, a plurality of openings through the inner peripheral surface from the outer surface 45 is formed. Struts 41, the width of the adjacent than sites circumferential direction (rotational direction Y) has a relatively wide wide portion 46, the opening 45 is formed in each of the wide portions 46. Opening 45 (four or five in this embodiment) a plurality along the extending direction of the struts 41 are formed, the inner edge of the opening 45, serves as the blade 47 for cutting the stenosis or occlusion . Position the blade 47 of the strut 41 is formed, the outer diameter of the struts 41 are located at the distal side than the portion having the maximum (substantially central portion in the direction along the rotation axis X) in the expanded state. Of the struts 41, the edges of the other inner edge constituting a cutting edge 47 of the opening 45 are preferably chamfered.

Struts 41, which opening 45 is five forming those four forms are arranged alternately in the circumferential direction. Therefore, when cutting the cutting portion 40 by laser processing or machining, etc. from a single tube, the four openings 45 and five apertures 45 can be staggered alternately, appropriate openings 45 it is possible to secure a width. Further, since the blade 47 of the struts 41 adjacent in the circumferential direction are displaced, it is possible to suppress, to cut the stenosis or occlusion effectively that a predetermined portion is scraped unevenly .

Struts 41, when the expanded state, the outer peripheral surface of the site where the blade 47 is formed is deformed so as to be inclined radially inwardly as the rotation direction Y side (see FIG. 6 (B)). Thus, the struts 41, when rotated in the expanded state, will be smoothly brought into contact with the contact object from the side is inclined radially inwardly of the struts 41, it is possible to reduce the excessive damage to living tissue. Also, the struts 41, which is formed by cut from small diameter of the tube than the diameter in the expanded state, the radius of curvature of the outer peripheral surface of the strut 41, from the axis of rotation X in the expanded state to the outer circumferential surface of the strut 41 smaller than the distance. Therefore, the edges of struts 41, further becomes less likely contact with the contact object, it is possible to further reduce the excessive damage to living tissue.

The material of the cutting unit 40 is, for example, a shape memory alloy the shape memory effect and super-elasticity is imparted by heat treatment, stainless steel, or the like can be suitably used. As the shape memory alloy, Ni-Ti-based, Cu-Al-Ni system, etc. Cu-Zn-Al-based or a combination thereof is preferably used.

Support 50 is arranged to support the cutting portion 40 radially inward of the cutting portion 40, by braiding a plurality of wires 51, between the adjacent wires 51 to the tubular so as to have a gap 52 It is formed. The distal end 54 of the support portion 50, a plurality of wires 51 are assembled in tubular, is fixed to the outer peripheral surface of the inner surface and the linear motion shaft 70 of the distal fixed end 42 of the strut 41 (FIG. 4 see). The proximal end 55 of the support portion 50, a plurality of wires 51 is set to the tubular, it is fixed to the proximal inner circumferential surface of the fixed end 43 of the strut 41.

Support portion 50, from a collapsed state in which a tubular outer diameter substantially uniform (see FIG. 3 (B)), by bringing the distal fixed end 42 and a proximal fixed end 43, the central portion is radially deformed to an expanded state to deflect outwardly (FIG. 3 (C), the reference to FIG. 4) can be a.

Maximum extension 53 outermost diameter larger of the support portion 50 in the expanded state, in a gap between the struts 41 keep the expanded state increases, projecting radially outward between the struts 41 (FIG. 6 (A ) see). Therefore, the most spread outward in contact with body tissue tends site of struts 41 in the expanded state is located radially inward of the maximum extension 53 of the support 50, the normal biological tissue by the edge of the strut 41 the damage can be suppressed.

The site in the vicinity of the blade 47 of the struts 41, the distance from the axis of rotation X is short (size is small), and since the wide portion 46 is formed, a narrow gap between the struts 41. Therefore, the supporting portion 50 located in the vicinity of the blade 47, since the protrusion from between the struts 41 radially outward can be suppressed, and contacting the blades 47 to be contacted without being inhibited in the support portion 50 possible (see Figure 6 (B)).

Wire 51 so as not to damage the living tissue in contact, less rigid than the struts 41, and it is preferable that a corner portion is formed with a curvature in cross-section, more preferably, a circular cross-section.

The outer diameter of the wire 51 is a suitably selected depending on the material and application conditions of the wire 51 or the like, for example, 0.05 ~ 0.15 mm.

The constituent material of the wire 51 is preferably a material which is flexible, for example, a shape memory alloy the shape memory effect and super-elasticity is imparted by heat treatment, stainless steel, Ta, Ti, Pt, Au, W, polyethylene, polyolefins such as polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine-based polymer ETFE, etc., PEEK (polyether ether ketone), polyimide, or the like can be suitably used. As the shape memory alloy, Ni-Ti-based, Cu-Al-Ni system, etc. Cu-Zn-Al-based or a combination thereof is preferably used. The structure obtained by combining a plurality of materials, for example, the structure and coated with Ni-Ti alloy core wire made of Pt, a structure gold-plated wire made of Ni-Ti alloy and the like in order to impart radiopacity .

Inner diameter in the contracted state of the cutting part 40 is a suitably selected depending on the inside diameter or the like of the applied living body lumen, for example, a 0.9 ~ 1.6 mm, be 1.4mm as an example it can. Outer diameter in the contracted state of the cutting part 40 is a suitably selected depending on the inside diameter or the like of the applied living body lumen, for example, a 1.1 ~ 1.8 mm, be 1.7mm as an example can. Length in the direction along the rotation axis X of the cutting portion 40 is a suitably selected to be applied, for example, a 10 ~ 30 mm, can be 20mm for example.

The maximum outer diameter in the expanded state of the cutting part 40 is a suitably selected depending inner diameter or the like of the applied living body lumen, for example, a 3.0 ~ 8.0 mm, be 7.0mm as an example it can.

The maximum expansion portion 53 of the support portion 50 in the expanded state, the projecting length of the struts 41 radially outward can be set as appropriate, for example, a 0.05 ~ 0.5 mm, 0.2 mm as an example it can be.

Drive shaft 60, as shown in FIGS. 1-4, it is formed in the tubular distal side is fixed to the proximal fixed end 43 of the cutting portion 40, and the driven gear 61 is fixed to the proximal side . The proximal portion of the drive shaft 60 is rotatably coupled to the casing 91 of the operation unit 90.

Drive shaft 60 is flexible, yet have properties capable of transmitting power of the rotating distally acting from the proximal side, for example, like the multi-layered coil, such as three-layer coils are alternately winding direction and the right lateral of the tube, polyethylene, polyolefin such as polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine-based polymer ETFE, etc., PEEK (polyether ether ketone), polyimide, or a reinforcing member such as a wire to a combination of these, are embedded It is composed of things.

The inner diameter of the drive shaft 60 is a suitably selected, for example, 0.7 ~ 1.4 mm, it is possible to 1.2mm as one example. The outer diameter of the drive shaft 60 is a suitably selected, for example, 0.8 ~ 1.5 mm, can be 1.35mm as an example.

Linear shaft 70, in order to expand and contract the cutting portion 40 and the support portion 50 is relatively movable tube in the direction of the rotation axis X with respect to the drive shaft 60, drive shaft 60, the cutting portion penetrate the 40 and the support portion 50. Linear shaft 70, the distal side is fixed to the distal end 54 of the wire 51, the proximal side, connected to a moving mechanism 92 for moving linearly along the linear shaft 70 to the rotation axis X It is. Inside the linear shaft 70, the guide wire can be inserted lumen 72 is formed.

The material of the linear shaft 70 is preferably a material which is flexible, for example, a shape memory alloy the shape memory effect and super-elasticity is imparted by heat treatment, stainless steel, Ta, Ti, Pt, Au, W, polyethylene, polyolefins such as polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine-based polymer ETFE, etc., PEEK (polyether ether ketone), polyimide, or the like can be suitably used. As the shape memory alloy, Ni-Ti-based, Cu-Al-Ni system, etc. Cu-Zn-Al-based or a combination thereof is preferably used. The may be composed of a plurality of materials, the reinforcing members such as wire may be embedded.

The inner diameter of the linear shaft 70 is a suitably selected, for example, 0.5 ~ 1.2 mm, can be 0.95mm as an example. The outer diameter of the linear shaft 70 is a suitably selected, for example, 0.6 ~ 1.3 mm, can be 1.05mm as an example.

The outer sheath 80 is a tubular body which covers the outside of the drive shaft 60, the drive shaft 60, it is possible and rotatable movement in a direction along the rotation axis X. The outer sheath 80 is adapted operable to grip a proximal portion, by moving distally is capable of accommodating the cutting portion 40 and the support portion 50 of the deflated state inside, proximally by causing moved, it is possible to expose the cutting unit 40 and the support portion 50 to the outside.

The material of the outer sheath 80 is not particularly limited, for example, polyethylene, polyolefin such as polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine-based polymer ETFE, etc., PEEK (polyether ether ketone), polyimide, and preferably It can be used. The may be composed of a plurality of materials, the reinforcing members such as wire may be embedded.

Inner diameter of the outer sheath 80 is a suitably selected, for example, 1.2 ~ 1.9 mm, it is possible to 1.8mm as one example. The outer diameter of the outer sheath 80 is a suitably selected, for example, 1.3 ~ 2.0mm, can be 2.0mm as one example.

Tip tube 75 is secured to the distal side of the translation shaft 70. Inside the tip tube 75 and lumen 76 is formed, the lumen 76 is in communication with the lumen 72 of the linear shaft 70.

The material of the tip tube 75 is not particularly limited, for example, polyethylene, polypropylene, ethylene - propylene copolymer, ethylene - polyolefins, such as vinyl acetate copolymer, polyvinyl chloride, polystyrene, polyamide, polyimide, or combinations thereof, such as It can be suitably used.

Operation unit 90, as shown in FIGS. 1 and 2, a casing 91, a drive mechanism 93 for imparting rotational force to the drive shaft 60, the moving mechanism 92 for moving the linear motion shaft 70 along the rotation axis X It is equipped with a door.

Drive mechanism 93 includes a drive gear 94 that meshes with the driven gear 61, a motor 96 as a driving source with a rotation axis 95 which drive gear 94 is fixed, a battery 97, such as a battery for supplying electric power to the motor 96, and a switch 98 for controlling the driving of the motor 96. By rotating the rotary shaft 95 of the motor 96 to put the switch 98, a driven gear 61 meshing with the drive gear 94 is rotated, the drive shaft 60 is rotated. When the drive shaft 60 is rotated, the distal cutting portion is fixed to the side 40 of the drive shaft 60, the support portion 50 and the tip tube 75 is rotated.

Moving mechanism unit 92 moves the operator dials 100 that can be rotated by a finger, and coaxially connected to the rotatable feed screw 101 to the dial 100, straight dynamically movable by the feed screw 101 a pedestal 102 is fixed to the moving base 102 includes a bearing portion 103 for rotatably holding the linear shaft 70, a.

Dial 100, together is rotatably held in the casing 91 is exposed outer circumferential surface from the opening 104 formed in the casing 91, it is rotatable by operating the outer peripheral surface with a finger. Feed screw 101 is rotatably held in the casing 91. Moving base 102 is formed internal thread feed screw 101 is screwed, is a straight dynamically movable along the non-rotating manner and rotary axis X relative to the casing 91. The bearing portion is fixed to the moving base 102 103 for applying a moving force to the linear motion shaft 70 with the movement of the moving table 102 is preferably a thrust bearing capable of receiving a thrust force.

Filter device 30, as shown in FIG. 1, 7, and a filter device 110 having a function as a filter, and a retractable sheath 120 filter device 110.

Filter device 110 comprises a filter unit 111 that is braided by a plurality of wires 112, and a long shaft portion 113 which is connected to the filter unit 111 through the filter portion 111.

Filter unit 111 shrinks by being housed in the sheath 120, it is released from the sheath 120 can be extended by the self-expansion force. Filter unit 111 is connected to the shaft portion 113 becomes distally closed cage, the proximal, is connected to the shaft portion 113 with a plurality of wires 112 are collected twisted.

The outer diameter of the wire 112 is a suitably selected depending on the material and application of the wire 112, for example, 20 ~ 100 [mu] m, as an example, can be 40 [mu] m.

The material of the wire 112 is preferably a material which is flexible, for example, a shape memory alloy the shape memory effect and super-elasticity is imparted by heat treatment, stainless steel, Ta, Ti, Pt, Au, W, polyethylene , polyolefins such as polypropylene, polyamides, polyesters such as polyethylene terephthalate, fluorine-based polymer ETFE, etc., PEEK (polyether ether ketone), polyimide, or the like can be suitably used. As the shape memory alloy, Ni-Ti-based, Cu-Al-Ni system, etc. Cu-Zn-Al-based or a combination thereof is preferably used. The structure obtained by combining a plurality of materials, for example, the structure and coated with Ni-Ti alloy core wire made of Pt, a structure gold-plated wire made of Ni-Ti alloy and the like in order to impart radiopacity .

The material of the shaft portion 113 is not particularly limited, for example, stainless steel, etc. shape memory alloy can be suitably used.

The sheath 120 includes a tube 121, a hub 122, and a anti-kink protector 123. Tube 121 has a lumen 124 that can accommodate a filter device 110, and is open at the tube opening 126 which is formed at the distal end. Hub 122 is fixed to the proximal end of the tube 121, and a hub opening 125 that communicates with the lumen 124. Kink protector 123 is a flexible member for covering the connecting portion of the tube 121 and the hub 122, to suppress the kink tube 121.

The constituent material of the tube 121 is not particularly limited, for example, polyethylene, polypropylene, ethylene - propylene copolymer, ethylene - polyolefins, such as vinyl acetate copolymer, polyvinyl chloride, polystyrene, polyamide, polyimide, or combinations thereof, such as It can be suitably used.

Next, a method for using the medical device 10 according to this embodiment, as an example when cutting the constriction of blood vessels.

First, the upstream side of the narrowed portion S of the blood vessels in (proximal) percutaneously inserting the introducer sheath (not shown) into a blood vessel, through the introducer sheath, the guide wire 130 in a blood vessel to insert to. Then, it pushed the guidewire 130, as shown in FIG. 8 (A), to reach the proximal side of the stenosis S. Thereafter, to insert the proximal end of the guide wire 130 located outside the body to the distal side of the catheter opening 141 of the guiding catheter 140, as shown in FIG. 8 (B), along the guide wire 130 the guiding catheter 140 is inserted into a blood vessel, to reach the proximal side of the stenosis S.

Then, after inserting the proximal end of the guide wire 130 located outside the body to the distal side of the catheter opening 151 of the support catheter 150 was forced to support catheter 150 to the proximal side of stenosis S, FIG. as shown in 9 (a), bring the support catheter 150 and guide wire 130 to the distal side of the stenosis S. Thereafter, the support catheter 150, leaving in the blood vessel, is pulled out of the guide wire 130.

Next, prepare the filter device 30 accommodating the filter device 110 to sheath 120. Filter unit 111 is located closer to the distal end of the tube 121 of the sheath 120, the shape is constrained in a contracted state. Next, as shown in FIG. 9 (B), the filter device 30 is inserted into a blood vessel through a support catheter 150, to reach the distal side of the stenosis S. After this, it is pulled out of the support catheter 150.

Next, the sheath 120 is relatively moved to the proximal side relative to the filter device 110, it protrudes distally filter portion 111 from tube 121. Thus, as shown in FIG. 10 (A), the filter unit 111 is a expanded state by the restoring force of the self, the outer peripheral portion of the filter portion 111 became cage is in contact with the inner wall surface of the vessel. At this time, the filter unit 111 is open toward the narrowing portion S of the upstream (proximal). Thereafter, leaving the filter device 110, it is pulled out of the sheath 120.

Then, the cutting portion 40 and the support portion 50 is contracted to prepare the treatment device 20 of the accommodated state to the outer sheath 80, the proximal end of the shaft portion 113 to the distal opening of the tip tube 75 insert and, as shown in FIG. 10 (B), to reach into the blood vessel through the guiding catheter 140. Next, as shown in FIG. 11 (A), the outer sheath 80 is moved proximally, the cutting portion 40 and the support portion 50 is exposed within the vessel. In this state, the cutting portion 40 and the support portion 50 is in a state in which contracted. Thereafter, as shown in FIG. 2, rotating the dial 100 to move proximally side movable carriage 102 feed screw 101 is rotated, linked linear shaft 70 proximally to the moving base 102 to move to. When the linear motion shaft 70 is moved proximally side, moves as the distal fixed end 42 of the cutting portion 40 approaches the proximal fixed end 43, as shown in FIG. 11 (B), the cutting portion 40 and the support portion a state in which 50 is expanded radially outward. Then, the size of the cutting portion 40 and the support 50 is adjustable as desired by the amount of rotation of the dial 100. Thus, as compared with the case of cutting using a rotating body with attached abrasive or the like to the outer surface of the balloon diameter during extension is defined, the cutting unit 40, the size desired size at the time of expansion it is adjustable arbitrarily, it is possible to effectively cut.

Next, put a switch 98 of the operation unit 90, the driving force of the motor 96 is transmitted from the drive gear 94 to the driven gear 61, the drive shaft 60 which is connected to the driven gear 61 is rotated, connected to the drive shaft 60 by cutting part 40 and the support portion 50 is rotated it is. When the cutting portion 40 and the support portion 50 is rotated, linear shaft 70 which is connected thereto at the distal end is also rotated. Incidentally, the proximal portion of the linear shaft 70, because it is supported by the bearing unit 103, be rotated, can be maintained expanded state of the cutting portion 40 and the support portion 50.

Next, while rotating the cutting portion 40 and the support portion 50, as shown in FIG. 12 (A), it forces the treatment device 20. Thus, the blade 47 formed on the cutting portion 40, contacts the stenosis S, flows stenosis product is scraped by the distal become debris D to (downstream side). Debris D flowing to the distal side, enters the inside of the filter portion 111 located at the distal side and is collected as taken strained by the filter unit 111. This can prevent the debris D flows into the peripheral, it is possible to suppress the generation of new stenosis in peripheral blood vessels.

Then, when cutting the stenosis S, the maximum extension 53 outermost diameter larger of the support portion 50 is, for projecting radially outward between the struts 41, the biological tissue extends to the outermost struts 41 contact easy site is located radially inward of the maximum extension 53 (see FIG. 6 (a)). Thus, the maximum extension 53 of the support portion 50 is less affected on the biological tissue than the struts 41, in contact with living tissue, it is possible to suppress damage to normal biological tissue by the edge of the strut 41, a safety it is possible to increase. Further, the most spread outwardly in contact with body tissue tends site of the struts 41, because no blade 47 is formed, it is possible to suppress damage to normal biological tissue, it is possible to improve safety. Furthermore, the site in the vicinity of the blade 47 of the struts 41, the distance from the axis of rotation X is short (size is small), and since the wide portion 46 is formed, radially outwardly from between the support 50 is strut 41 protruding into and hardly can be contacted blade 47 to stenosis S without being inhibited in the support portion 50.

Also, the struts 41, the outer peripheral surface of the site where the blade 47 is formed, for deforming to tilt radially inward as the rotation direction Y side (see FIG. 6 (B)), the radially inner side of the strut 41 tilted smoothly contact the contact object, such as a stenosis S and the living tissue from the side which can reduce excessive damage to living tissue. Also, the struts 41, because they are cut from small diameter of the tube than the diameter in the expanded state, the radius of curvature of the outer peripheral surface of the strut 41, than the distance from the rotation axis X in the expanded state to the outer circumferential surface of the strut 41 small. Therefore, the edges of struts 41, further becomes less likely contact with the object, it is possible to further reduce the excessive damage to living tissue.

Further, since the support portion 50 provided on the inner side of the strut 41, between the adjacent struts 41, hard debris D dropped out is less likely sandwiched, does not increase the struts 41 turned up outwardly, Ya damage struts 41 break can be suppressed.

Also, the struts 41 the blade 47 is formed, by being supported by the supporting unit 50, since the radial force (force in the radial direction) is increased, despite the expandable and contractible structure, high cutting capability the can be exhibited. Further, since the gap between the strut 41 is compensated by the supporting portion 50, cross section becomes substantially circular overall by struts 41 and the support portion 50, it is possible to center the cutting unit 40 in position. Further, a portion of the debris D generated is cut by the blade 47 of the struts 41, it may be recovered by collecting in the support portion 50.

After cutting the stenosis material is completed, it stops the rotation of the drive shaft 60 to turn off the switch 98. Then, the dial 100 is rotated in the reverse rotation to the time obtained by extending the cutting portion 40 and the support portion 50, as shown in FIG. 1, the moving base 102 feed screw 101 rotates and distally move, the linear motion shaft 70 coupled to the movable carriage 102 moves distally. When the linear motion shaft 70 is moved distally, a state where the distal fixed end 42 of the cutting portion 40 is moved away from the proximal fixed end 43, the cutting portion 40 and the support portion 50 is contracted radially inward Become. Thereafter, moving the outer sheath 80 distally, as shown in FIG. 12 (B), containing a cutting portion 40 and the support portion 50 to the outer sheath 80, the treatment device 20 through the guiding catheter 140 the be withdrawn.

Next, insert the proximal end of the shaft portion 113 to tube opening 126 of the sheath 120 (suction catheter), as shown in FIG. 13 (A), the sheath 120 through the guiding catheter 140 It is inserted into a blood vessel. In this state, connect the Y connector (not shown) so as to communicate with the hub opening 125 of the sheath 120, to connect the syringe to the opening towards the shaft portion 113 is not inserted in the Y connector. Thereafter, when the action of suction force by pulling the pusher of the syringe, negative pressure is generated in the lumen 124 extending from the distal side to the proximal side, the tube debris D in the filter portion 111 opening 126 it can be from drawn into the lumen 124. When sucking the debris D by syringe, if necessary, by advancing and retracting the tube 121, it is possible to effectively suck the debris D. In this manner, by pulling by sucking some or all of the debris D in the filter unit 111 into the lumen 124, a state where the filter unit 111 is likely to shrink. Incidentally, the instrument for sucking the debris D (suction catheters) may be different from the catheter and sheath 120. Further, the instrument exerting a suction force is not limited to a syringe, it may be, for example, a pump.

Then, by moving the shaft portion 113 to the relatively distal with respect to the sheath 120, as shown in FIG. 13 (B), lumen of the filter unit 111 is driven by the shaft portion 113 tube 121 124 to move within.

Thereafter, the filter device 110 is withdrawn along with sheath 120, and removed the guiding catheter 140 and introducer sheath, the procedure is completed. Incidentally, the filter device 110, rather than accommodating the sheath 120 may be housed directly guiding catheter 140 without a sheath 120. In this case, the debris D may not removed by suction.

As described above, the medical device 10 according to the first embodiment, a device for cutting an object of a living body lumen, a rotatable drive shaft 60, coupled to a distal side of the drive shaft 60 rotation is possible, it rotates with extending along the rotation axis X and the at least one strut 41 can be extended radially outward by the central portion is bent, is connected to the distal side of the drive shaft 60 Te are possible, extend a plurality of gaps at least a portion is formed on the mesh and the tubular is positioned radially inwardly of the struts 41, radially outward by the central part of the direction is bent along the rotation axis X possible is having a supporting portion 50, a. Thus, the struts 41 and the support portion 50 while facilitating the transportation of the body lumen, can ensure proper cutting range by expanding. Furthermore, the medical device 10, since the supporting portion 50 supports the strut 41 from the radially inner side, while reducing excessive damage to biological tissue by the edge of the strut 41, the object is sandwiched in the gap of the struts 41 frame is possible to suppress the device damage and breakage by suppressed.

Also, the struts 41, because the blade 47 for cutting the object at the position of the distal side of the portion that most extended radially outward in the expanded state is formed, and the blade 47 hardly contacts the living body tissue while ensuring safety blades 47 by pushing the struts 41 to the stenosis S in contact to the object of the body lumen, it is possible to cut the object effectively.

The maximum extension 53 for most extended radially outward of the supporting portion 50 in the expanded state, in order to protrude from between the struts 41 radially outward than the struts 41, the influence of the body tissue than the struts 41 in contact with the small maximum extension 53 of the support portion 50 is body tissue, it is possible to suppress damage to normal biological tissue by the edge of the strut 41, it is possible to improve safety.

Also, the struts 41 in the expanded state, the outer peripheral surface of the site where the blade 47 is formed, because of the inclined more radially inward direction of rotation Y side, the contact from the side that is inclined radially inwardly of the struts 41 smoothly contacts the subject, can reduce the excessive damage to the biological tissue by struts 41.

Also, the struts 41 has a relatively wide wide portion 46 than the portion where the width in the circumferential direction are adjacent, since the blade 47 on the wide portion 46 is formed, radially outward of the supporting portion 50 the inhibition by projecting the wide portion 46, can be good contact blade 47 without being inhibited by the support portion 50 to be contacted.

The length of the maximum extension 53 in the expanded state protrudes from the strut 41 to the radially outward, than the length of the support portion 50 from between the struts 41 at a site wide portion 46 is disposed to protrude outward in the radial direction large, even while the maximum extension 53 to suppress damage to the normal biological tissue by struts 41 in contact with the body tissue, the object of the blades 47 of the strut 41 is effectively contacted to the object of the body lumen it can be well cut.

Also, the struts 41, since it has an inclined portion 44 which is inclined with respect to the rotation axis X in contracted state, in the expanded state, the asymmetry of the shape of the inclined portion 44, inclined to a desired angle the outer peripheral surface of the strut 41 It can be set so that, the degree of freedom in design is improved. Thus, the struts 41, damage to living tissue less likely to occur, and it is possible to set the cutting easily angle the object body lumen. Further, since the inclined portion 44 is provided on the proximal side of the strut 41, in contact with the support 50 in the area portion of the proximal side is wider struts 41, the positional deviation of the struts 41 of the support portion 50 can be suppressed.

The present invention also provides a treatment method for cutting an object body lumen. The method of treatment, a rotatable drive shaft is rotatable coupled to a distal side of the drive shaft, extensible along the rotation axis radially outward by the central portion is deflected with extending at least one strut is rotatable coupled to a distal side of the drive shaft, at least a portion is formed on the net and the tubular comprises a plurality of gaps positioned radially inwardly of said struts and is carried out using a supporting portion at the central portion in the direction along the rotating shaft is deflected is expandable radially outward, a medical device having a. Then, the treatment method includes the steps of inserting into a body lumen in a state of being contracted the strut and the support part (i), the steps of expanding the (ii) the strut and the support portion, (iii) said strut and a step of the supporting portion for cutting the object of a living body lumen is rotated by the drive shaft, (iv) a step of contracting the strut and the support portion, (v) a body lumen the strut and the support portion It has the steps of removal, from. According to this treatment method, for inserting the strut and the support portion to the body lumen, while facilitating the transportation of the body lumen can also ensure proper cutting range. Furthermore, the method of treatment, for cutting an object by rotating the strut while supporting struts from the radially inner side by the support unit, while reducing the excessive damage to the living tissue by the edge of the strut, the gap of the strut device damage or breakage can be suppressed by suppressing that an object is sandwiched.

Further, the method of treatment described above, the in the step of expanding the strut and the support portion, the maximum extension of the most extended radially outward of the supporting portion, is protruded outward in the radial direction than the struts from between the struts it may be. Thus, the maximum extension of the support portion effects on living tissue is smaller than struts, in contact with living tissue, it is possible to suppress damage to normal biological tissue by the edge of the strut, it is possible to increase the safety .

Further, the method of treatment described above, prior to the step of cutting the object of a living body lumen, comprising the step of placing the filter unit into a body lumen, after the step of cutting the object body lumen a step of collecting the objects body lumen by the filter unit, the steps of removing the said filter portion from the body lumen may have. Thus, an object that occurred scraped by blade strut (debris) can be removed by collecting the filter section, the debris can be inhibited new stenosis or occlusion flows to peripheral occurs .
<Second Embodiment>

Medical device 200 according to the second embodiment of the present invention, in particular, the cutting unit 40, the configuration of the outer sheath 80 and the operation unit 90 is different from the first embodiment. Note that the portion having the same functions as in the first embodiment are denoted by the same reference numerals, and description thereof is omitted.

Medical device 200 according to the second embodiment of the present invention, as shown in FIG. 14, the treatment device 210 for cutting the stenosis or occlusion, and falling off scraped off from the stenosis or occlusion debris to (object) a filter device 30 for trapping, and a.

Treatment device 210, as shown in FIGS. 14 and 15, the expansion and contraction can cutting portion 220 radially outward, and a support portion 230 for supporting the cutting portion 220, a drive shaft 240 for rotating the cutting portion 220 , and a linear motion shaft 250 to adjust the amount of deformation of the cutting unit 220. Furthermore, the treatment device 210 includes a tip tube 260 is coupled to the distal side of the translation shaft 250, an outer sheath 270 which can accommodate the cutting portion 220, an inner tube 280 disposed inside of the linear shaft 250 , and an operation portion 290 for operating provided proximally. Furthermore, the treatment device 210 includes a control unit 300 for controlling the drive of the drive shaft 240, pushing and pulling resistance measuring unit 310 which is attached to the drive shaft 240 (the detection unit), a proximal portion of the drive shaft 240 and the linear motion shaft 250 a connecting portion 320 which connects the, and a notification unit 400 to notify that the cutting resistance exceeds a threshold value.

Cutting unit 220 comprises a strut 41 of the at least one extending along the rotation axis X of the drive shaft 240 (four in this embodiment) is integrally formed with the strut 41 distal to all of the struts 41 a distal end 221 of the tubular, and a proximal fixed end 43 of the tubular which is formed integrally with the strut 41 at the proximal side of all of the struts 41. The distal end portion 221, without being fixed to the support portion 230 and the linear motion shaft 250, the supporting portion 230 and the linear motion shaft 250 are relatively movable in the axial direction. The distal end portion 221 by the linear motion shaft 250 is moved proximally with respect to the cutting portion 220 in contact with the proximal portion of the distal tube 260 coupled to the linear motion shaft 250 (see Figure 20 ).

Support portion 230 is arranged to support a cutting portion 220 radially inward of the cutting portion 220, by braiding a plurality of wires 231, between the adjacent wire 231 in tubular so as to have a gap 232 It is formed. The distal end 234 of the support portion 230, a plurality of wires 231 are assembled in tubular, without being fixed to the inner surface of the distal end portion 221 of the cutting portion 220, the outer peripheral surface of the linear motion shaft 250 It has been fixed. The proximal end 235 of the support 230, a plurality of wires 231 are assembled in tubular, it is fixed to the proximal inner circumferential surface of the fixed end 43 of the strut 41.

Some of the plurality of wires 231 are wires constituted by X-ray contrast material. Thus, the position and expanded diameter of the support portion 230 and the cutting portion 220, it is possible to accurately grasp under X-ray fluoroscopy, the procedure is made more easily. The X-ray contrast material, for example, gold, platinum, platinum - iridium alloy, silver, stainless steel, molybdenum, tungsten, tantalum, palladium, or an alloy thereof and the like. Incidentally, instead of the support portion 230, a part of the cutting portion 220 may be configured with X-ray contrast material. For example, the inner peripheral surface of the cutting portion 220 may be covered by plating the X-ray contrast material. Thus, the position and expanded diameter of the support portion 230 and the cutting portion 220, it is possible to accurately grasp under X-ray fluoroscopy, the procedure is made more easily.

Supporting portion 230, from a collapsed state in which a tubular outer diameter substantially uniform (see FIG. 15), by bringing the distal end 234 and a proximal end 235, radially outward the central portion modified as flexes can be expanded condition (see Figure 20). The central portion of the supporting portion 230 is bent radially outward, while the distal end portion 234 gradually closer to the tip tube 260, the struts 41 are arranged outside of the supporting portion 230, the diameter by the supporting portion 230 Extending is pushed outward. Until the tip tube 260 is in contact with the distal end portion 234, as shown in FIG. 20 (A), the cutting portion 220, a distal end portion 221 is not fixed to the support portion 230 and the linear motion shaft 250 Therefore, the force in the axial direction between the distal end 221 and a proximal fixed end 43 hardly acts to expand only by the force of the radially outward for receiving the support 230. Therefore, a gap is hardly generated between the struts 41 and the wire 231, constriction materials and debris between the struts 41 and the wire 231 is not pinched, it is possible to suppress damage to the struts 41, and normal by the edges of the struts 41 damage such biological tissue can be suppressed. When the tip tube 260 to move together with the linear motion shaft 250 contacts the distal end portion 221, as shown in FIG. 20 (B), the distal end portion 221 receives a force in the proximal direction from the tip tube 260, the shaft force to shrink in the direction acts. Thus, the struts 41 are not only force in the radially outward for receiving the support 230, also will be extended by contraction force. Therefore, while maintaining the desired state in which a gap is hardly generated between the struts 41 and the wire 231 can be suppressed to press the cutting portion 220 by the support 230 more than necessary.

Drive shaft 240, as shown in FIG. 15 and 16, are formed in the tubular distal side is fixed to the proximal fixed end 43 of the cutting portion 220, and the driven gear 61 is fixed to the proximal side . Drive shaft 240, at least a portion the fluid plurality of holes 241 can flow are formed through the outer peripheral surface from the inner circumferential surface. A part of the outer peripheral surface of the proximal portion of the drive shaft 240 in slidable contact with the first seal portion 355 in the operation unit 290, the covering portion 242 for reducing the frictional force is covered.

Construction material of the coating section 242 is preferably a low friction material, for example, a fluorine-based resin material such as polytetrafluoroethylene (PTFE). Hole 241 of the drive shaft 240, as shown in FIG. 17 may be configured as a plurality of through holes provided in the tubular body, or, as shown in FIG. 18, the wire 243 braided were the braid it may be constituted by a gap formed. Further, the drive shaft 240 and a coil, the hole 241 may be a gap between the coil. Hole 241 may be formed on the entire drive shaft 240, or may be partially formed. Using braid or coil, if the hole portion 241 to form a drive shaft 240 which is provided only in a predetermined range, the braid or coil having a gap, by covering the material such as resin partially, easily It can be formed on.

Linear shaft 250, as shown in FIG. 15 and 16, in order to expand and contract the cutting portion 220 and the support 230, movable relative tube in the direction of the rotation axis X with respect to the drive shaft 240 , and the passes through the drive shaft 240, the cutting section 220 and the support 230. Linear shaft 250, distal side is fixed to the distal end 234 of the wire 231, the proximal side, connected to a moving mechanism portion 340 for moving linearly along the linear motion shaft 250 to the rotation axis X It is. Proximal linear shaft 250 protrudes proximally than the drive shaft 240. Linear shaft 250, at least a portion, the hole portion of the plurality allowing flow fluid is formed through the outer peripheral surface from the inner circumferential surface. Hole 251 of the linear motion shaft 250, similar to the hole portion 241 of the drive shaft 240 may be configured as a plurality of through holes provided in the tubular body, or be constituted by a gap of braid or coil good.

Connection 320 is a member of the extendable tubular connecting the proximal portion of the proximal portion and the driver shaft 240 of the linear motion shaft 250 is reduced in diameter in a tapered shape toward the proximal direction. Connection 320, to the linear motion shaft 250 and drive shaft 240, is connected in a liquid-tight manner. Connecting portion 320, while maintaining liquid tightness between the linear shaft 250 and drive shaft 240 in the operation unit 290 to permit movement in the axial direction with respect to the drive shaft 240 of the linear motion shaft 250. The stretchable connection part 320, by connecting the linear motion shaft 250 and drive shaft 240 to move relative eliminates the need to employ a sealing structure causing friction, such as O-ring, resulting in loss of driving force without let, you can maintain the liquid-tightness between the linear shaft 250 and drive shaft 240. The connecting portion 320 can absorb the rotational direction of displacement of the linear shaft 250 and the drive shaft 240 by twisting.

The material of the coupling portion 320 is long if not particularly limited stretchable, such as natural rubber, isoprene rubber, butadiene rubber, chloroprene rubber, silicone rubber, fluorine rubber, styrene - and various rubber materials such as butadiene rubber, styrene , polyolefin, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluororubber, various thermoplastic elastomers such as chlorinated polyethylene can be suitably used.

Outer sheath 270 is a tubular body which covers the outside of the drive shaft 240 is movable in a direction along the rotation axis X. Outer sheath 270 is adapted operable to grip a proximal portion, by moving distally is capable of accommodating the cutting portion 220 and the support portion 230 of the deflated state inside, proximally by causing moved, it is possible to expose the cutting unit 220 and the support portion 230 to the outside.

The inner tube 280 is disposed in the interior of the linear shaft 250, a tube body filter device 30 and guide wire or the like therein can be inserted lumen 281 is formed, against the linear motion shaft 250, the rotation it is movable in a direction along the axis X. The inner tube 280 is at least partially, the fluid is a plurality of holes 282 can flow are formed through the outer peripheral surface from the inner circumferential surface. Hole 282 of the inner tube 280, similar to the hole portion 241 of the drive shaft 240 may be configured as a plurality of through holes provided in the tubular body, or may be constituted by a gap between the braid and coil .

Tip tube 260 is secured to the distal side of the translation shaft 250. Inside the tip tube 260, inner tube 280 is disposed. The outer peripheral surface of the tip tube 260, a plurality of protrusions 261 are formed. Convex portion 261, for example, may be formed by embossing, micro or formed by providing a plurality of holes, or, or to adhere the fine metal powder or the like on the surface of the tip tube 260, the material of the tip tube 260 metal powder or the like can be formed by mixing. Material of the metal powder, for example, can be suitably used stainless steel.

Pushing and pulling resistance measuring unit 310 (detection unit), as shown in FIG. 14, pushing and pulling resistance acting on the drive shaft 240 to the cutting portion 220 and the support 230 when pulled back and when pushed into the constriction (axial resistance ) a sensor 311 for detecting, and a measurement device 312 for calculating a push-pull resistance in response to a signal from the sensor 311. Sensor 311 is, for example, a strain gauge attached to the vicinity of the first bearing portion 331 for receiving the push-pull resistance. Measuring device 312 calculates the push-pull resistance from a signal received from the sensor 311, and transmits the result to the control unit 300. Incidentally, the site where the sensor 311 is mounted, as long as it can detect the pushing and pulling resistance of the drive shaft 240 is not particularly limited.

Operation unit 290, as shown in FIG. 14 and 16, a drive mechanism 330 for imparting rotational force to the drive shaft 240, a moving mechanism 340 for moving the linear motion shaft 250 along the rotation axis X, the outer sheath and a liquid feeding portion 350 for feeding the physiological saline into the 270.

Feeding portion 350 includes a first housing 351 having an outer sheath 270 is fitted, the storage bag 352 containing the physiological saline, a pressure bag 353 for pressurizing the storage bags 352, storage bags 352 and first a connecting tube 354 connecting the housing 351, and a first seal portion 355 which is disposed in the first housing 351, a fixing portion 358 for fixing the first sealing portion 355.

The first housing 351 is a tubular member, the second guiding portion 356 which projects slidably fitted in the linear second guide groove 335 formed in the second housing 333 in which the motor 96 is accommodated it is formed on an outer peripheral surface and is movable along the axial direction relative to the second housing 333. The first housing 351, the outer sheath 270 is fitted and fixed from the distal side. The first seal portion 355 is, for example, a O-ring and X-ring is disposed within the proximal portion of the first housing 351, the outer periphery of the drive shaft 240 which enters the first housing 351 through the interior of the outer sheath 270 slidably contacts the cover portion 242 of the surface. The first seal portion 355 is fixed by the fixing portion 358 screwed from the proximal side to the first housing 351. The first sealing unit 355, while allowing rotation and movement in the axial direction of the drive shaft 240, to maintain the liquid-tight state between the drive shaft 240 and the first housing 351.

The first housing 351 is the port portion 357 connecting tube 354 is connected extending from storage bag 352 is formed, saline supplied from storage bag 352, the port portion 357 in the first housing 351 It can flow in. Saline pressurized flowing into the first housing 351, the first seal portion 355 to flow to the proximal side is restricted, it can flow into the distal side of the outer sheath 270. In the present embodiment, liquid feed unit 350 is slidably coupled to the second housing 173, feeding unit, be configured independently without being connected to the second housing good. In this way, feeding unit, without being limited to the size of the second housing, it is possible to move a wide range.

Drive mechanism 330 includes a drive gear 94 that meshes with the driven gear 61, a motor 96 as a driving source with a rotation axis 95 which drive gear 94 is fixed, a control unit 300 for controlling the supply of current to the motor 96 , and a first bearing portion 331 and the second bearing portion 332 for rotatably supporting the linear motion shaft 250. Furthermore, the driving mechanism portion 330 includes a second housing 333 that houses the motor 96, while being connected to the second housing 333, and a frame 334 which holds the first bearing portion 331 and the second bearing portion 332 there.

The second housing 333, as described above, a box-shaped member for housing the motor 96, the outer surface, the second guide groove 335 in which the second guiding portion 356 of the first housing 351 is fitted slidably formed It is.

Frame 334 includes a first partition wall 336 and the second partition wall 337 parallel, the second housing 333 is fixed to the first partition wall 336 of the distal, the second partition wall 337 proximally moving mechanism part 340 is fixed.

The first partition wall 336, the rotary shaft 95 extending from the motor 96 in the second housing 333 is penetrated, during the first partition wall 336 and the second partition wall 337, the drive gear 94 is disposed. The first partition wall 336, the first bearing portion 331 is disposed, the drive shaft 240 extending from the first housing 351 is rotatably held by the first bearing portion 331. Driven gear 61 fixed to the drive shaft 240 is located between the first partition wall 336 and the second partition wall 337 is engaged with the drive gear 94. The second partition wall 337, the second bearing portion 332 for rotatably supporting the drive shaft 240 is disposed.

To supply power to the motor 96 through the cable 301, when the rotary shaft 95 of the motor 96, a driven gear 61 meshing with the drive gear 94 rotates, is supported by the first bearing portion 331 and the second bearing portion 332 drive shaft 240 is rotating. When the drive shaft 240 is rotated, the cutting portion 220 which is secured to the distal side of the drive shaft 240, the support portion 230 and the tip tube 260 is rotated. Since the distal end 234 of the support portion 230 is joined to the linear motion shaft 250, the support 230 is rotated, the linear motion shaft 250 is also rotated to follow the support 230.

Moving mechanism part 340, as shown in FIGS. 14, 16 and 19, and the operator can rotate with a finger dial 360, a movable table 370 which is movable straight dynamically by the rotation of the dial 360, the mobile a third bearing portion 341 for rotatably holding the linear shaft 250 is fixed to the base 370, and the second seal portion 342, and a proximal anchor portion 380 for fixing the second seal portion 342. Furthermore, the moving mechanism portion 340 includes a third housing 390 that accommodates the moving stand 370. The inner surface of the third housing 390, linear first guide groove 391 in which the first guiding portion 371 that protrudes is formed on the movable carriage 370 is slidably fitted is formed.

Dial 360 is a cylindrical member disposed at the proximal side of the frame 334, it is rotatable by operating the outer peripheral surface with a finger. Dial 360, a portion of the distal portion is positioned inside the third housing 390. Dial 360 is formed with a groove portion 362 extending to the outer peripheral surface in the circumferential direction, the movement in the axial direction is restricted fitted hook portion 392 formed at the proximal portion of the third housing 390, It is rotatably held relative to the third housing 390. The inner peripheral surface of the dial 360, the screw groove 372 and screwed feed screw 361 which is formed on the moving base 370 is formed. Dial 360, discharge hole 366 for removing the air inside is formed at the time of priming. Discharge hole 366 can be opened and closed with a plug 367.

Moving stand 370, together with the first guiding portion 371 to be fitted into the first guide groove 391 of the third housing 390 is formed, the feed screw 361 is threaded groove 372 to be engaged is formed. Therefore, by the feed screw 361 is rotated, a straight dynamically movable along the non-rotating manner and rotary axis X relative to the third housing 390. Third bearing portion 341 that is fixed to the moving base 370 for applying a moving force to the linear motion shaft 250 with the movement of the moving stand 370, axial force (thrust force) in a bearing capable of receiving the there it is preferable. The proximal side of the third bearing portion 341, the other sealing member may be provided.

The second seal portion 342, the proximal side of the dial 360, can accommodate the recess 364 linear shaft 250 of the dial 360 is formed to surround the through hole 363 that penetrates. The second seal portion 342 is an annular member in contact with the outer peripheral surface of the proximal portion of the linear shaft 250 therein.

Proximal fixing part 380 is a bolt-like member capable screwing so screwed into the screw groove 365 formed in the recess 364 of the dial 360, the through hole 381 of inner tube 280 is disposed within It is formed. Proximal fixing part 380, that are screwed into the recess 364 of the dial 360, the inner tube 280 is pressed by deforming the second seal portion 342, maintained between dial 360 and inner tube 280 in liquid-tight manner while, holding the inner tube 280.

Control unit 300 supplies the current to the motor 96 through the cable 301, also functions as a detection unit for detecting a change of the current supplied, the cutting resistance in the cutting section 220 which is rotated by a motor 96 (rotating direction of resistance) can detect. The control unit 300 receives from the measuring apparatus 312, receives a measurement result of pushing and pulling resistance acting on the drive shaft 240 (axial resistance). Control unit 300, if it exceeds a threshold cutting resistance is preset, the rotation of the motor 96 is stopped, the notification unit 400 to display that the threshold is exceeded. The control unit 300, when the cutting resistance is greater than the threshold value, instead of stopping the rotation of the motor 96 may reduce the rotational speed. Further, the control unit 300, if it exceeds a threshold pushing and pulling resistance is preset, the rotation of the motor 96 is stopped, the notification unit 400 to display that the threshold is exceeded. The control unit 300, when the pushing and pulling resistor exceeds a threshold, instead of stopping the rotation of the motor 96 may reduce the rotational speed.

Notification unit 400 includes a monitor 401 and a speaker 402 is communicatively connected to the control unit 300. Monitor 401 notifies the display to the operator that the cutting resistance or push-pull resistance has exceeded the threshold. Speaker 402, that cutting resistance or push-pull resistance exceeds a threshold value, notifies the operator by sound. The control unit 300, when the cutting resistance or push-pull resistance exceeds the threshold, without stopping the rotation of the motor 96, may only be notified by the notification unit 400. In this case, the operator receives a notification of visual or hearing from the notification unit 400, or to stop the motor 96, or to stop pushing or a pulling back, rotate the dial 360 to change the diameter of the cutting portion 220 or can.

Next, a method for using the medical device 200 according to the second embodiment, an example in which cutting a narrowing of the blood vessel. Until installing the filter device 110 is similar to the method described in the first embodiment.

First, similarly to the method described in the first embodiment, percutaneously inserting the introducer sheath (not shown) into a blood vessel in the upstream side of the narrowed portion S of the vessel (proximal), the intro through the sheath to reach the guidewire 130 until the proximal side of the stenosis S. Thereafter, as shown in FIG. 8 (B), the guiding catheter 140 along the guide wire 130 is inserted into a blood vessel, to reach the proximal side of the stenosis S.

Then, after the forced support catheter 150 along the guide wire 130 to the proximal side of stenosis S, as shown in FIG. 9 (A), the support catheter 150 and guide wire 130 than stenosis S distal to reach to the side. Thereafter, the support catheter 150, leaving in the blood vessel, is pulled out of the guide wire 130.

Next, prepare the filter device 30 accommodating the filter device 110 to sheath 120. Filter unit 111 is located closer to the distal end of the tube 121 of the sheath 120, the shape is constrained in a contracted state. Next, as shown in FIG. 9 (B), the filter device 30 is inserted into a blood vessel through a support catheter 150, to reach the distal side of the stenosis S. After this, it is pulled out of the support catheter 150.

Next, the sheath 120 is relatively moved to the proximal side relative to the filter device 110, it protrudes distally filter portion 111 from tube 121. Thus, as shown in FIG. 10 (A), the filter unit 111 is a expanded state by the restoring force of the self, the outer peripheral portion of the filter portion 111 became cage is in contact with the inner wall surface of the vessel. At this time, the filter unit 111 is open toward the narrowing portion S of the upstream (proximal). Thereafter, leaving the filter device 110, it is pulled out of the sheath 120.

Then, the cutting portion 220 and the support portion 230 is contracted to prepare a treatment device 210 in the state accommodated in the outer sheath 270, the pressurized storage bags 352 by the pressure bag 353, from storage bags 352 connecting tube 354 supplying physiological saline through to the first housing 351. Saline flowing into the first housing 351, as shown in FIG. 21, is restricted to move in the proximal direction by the first sealing portion 355, it moves through the outer sheath 270 in the distal direction. Saline flowing into the outer sheath 270, upon reaching the area where the hole portion 241 of the drive shaft 240 is formed, part of the saline to flow into the driving shaft 240 through the hole 241. Saline flowed to the drive shaft 240, upon reaching the area where the hole 251 of the linear motion shaft 250 are formed, a portion of the saline to flow into the linear motion shaft 250 through a hole 251 . Saline flowing into the linear motion shaft 250, upon reaching the area where the hole 282 of the inner tube 280 is formed, into the lumen 281 of inner tube 280 portion of saline through the holes 282 It flows.

Then, within the outer sheath 270, inner drive shaft 240, within the linear shaft 250, and inner tube 280 saline flowing into, as shown in FIG. 22, the outer sheath 270, the drive shaft 240, the linear motion shaft 250 , and it is discharged from the distal opening of the inner tube 280. Furthermore, physiological saline water flowing to the drive shaft 240, as shown in FIG. 23, the connecting portion 320 which is coupled to the proximal portion of the drive shaft 240 and the linear motion shaft 250, the movement is restricted. Saline flowing into the linear motion shaft 250 passes through the moving base 370 flows proximally, it flows to the dial 360. Saline flowed to the dial 360 is discharged to the outside through the discharge hole 366. After air in the moving base 370 and the dial 360 has passed through, it is possible to close the discharge hole 366 with a plug 367. Saline water flowing into the inner tube 280 is discharged to the outside from the opening of the proximal flow proximally. As a result, the priming is completed. Incidentally, feeding from storage bag 352, after this, it is continued until the procedure according to the treatment device 210 is completed. Further, priming treatment device 210 may be performed without using a pressure bag 353.

Then, by inserting the proximal end of the shaft portion 113 to the distal opening of the inner tube 280, as shown in FIG. 24 (A), the distal portion of the treatment device 210, the guiding catheter 140 to reach a blood vessel through. Then, the distal portion of the treatment device 210, under X-ray fluoroscopy, to position proximal to stenosis S. Treatment device 210, because it is constantly supplied saline by storage bag 352, the outer sheath 270, the drive shaft 240, the linear motion shaft 250, and the inflow of blood into the inner tube 280 is inhibited.

Next, as shown in FIG. 25, to move the first housing 351 to the proximal side relative to the second housing 333, as shown in FIG. 24 (B), the outer sheath 270 is moved proximally side cutting portion 220 and the support 230 is exposed within the blood vessel. In this state, the cutting unit 220 and the support 230 is in a state in which contracted proximal side from stenosis S.

Then, under X-ray fluoroscopy, for detecting the size of the gap of the stenosis S. Site detection of the size of the gap stenosis S may or visually detected from the X-ray imaging video, the gap between the narrowed portion S in the X-ray imaging video, for example, found that the size of the treatment device 210 (e.g., struts 41 or support 230) can be detected in comparison with. Also, intravascular ultrasound diagnostic apparatus (IVUS: Intra Vascular Ultra Sound), optical coherent tomography diagnosis apparatus (OCT: Optical Coherence Tomography), or optical frequency domain imaging method (optical frequency domain imaging: OFDI) by using the , it is also possible to detect the magnitude of the gap stenosis S in more detail.

Thereafter, as shown in FIG. 25, rotating the dial 360, the linear motion shaft 250 which feed screw 361 is moved proximally side moving base 370 to rotate, which is connected to the movable base 370, the drive shaft It moves to the proximal side with respect to 240. When the linear motion shaft 250 is moved proximally side approaches the distal end 234 and a proximal end 235, FIG. 20, as shown in FIG. 26 (A), the central portion is radial support 230 deformed so as to bend outwards the expanded state. The central portion of the supporting portion 230 is bent radially outward, struts 41 are arranged outside of the supporting portion 230, pressed to expand by the supporting portion 230 radially outward. At this time, the cutting portion 220, at the beginning of at least extended, since the distal end portion 221 is not fixed to the support portion 230 and the linear motion shaft 250, the shaft between the distal end 221 and a proximal fixed end 43 force in the direction does not act, as shown in FIG. 20 (a), extends only in force in the radially outward for receiving the support 230. Therefore, hardly a gap between the struts 41 and the wire 231. When the linear motion shaft 250 is moved to the proximal side relative to the drive shaft 240, as shown in FIG. 25, the connecting portion 320 extends for connecting the proximal portion of the proximal portion and the driver shaft 240 of the linear motion shaft 250 , it is maintained liquid-tight state, physiological saline water flowing between the linear shaft 250 and drive shaft 240 does not leak.

Then, the size of the cutting portion 220 and the support 230 is adjustable as desired by the amount of rotation of the dial 360. Thus, the cutting unit 220 is adjustable to any size when expanded to the desired size, it is possible to effectively cut.

When expanding the support 230 and the cutting portion 220 by rotating the dial 360, under X-ray fluoroscopy, while the expanded diameter of the cutting portion 220 compared to the clearance of stenosis S, than the gap of stenosis S greatly expanded. The outer diameter of the largest spread portion of the cutting portion 220 and the support portion 230 at this time is the magnitude between the maximum expanded state of being the most minimum deflated contracted state and the most extended.

Then, by rotating the motor 96 supplies current to the motor 96 by the control unit 300, the driving force of the motor 96 is transmitted from the drive gear 94 to the driven gear 61, the drive shaft 240 is coupled to the driven gear 61 is rotation to, coupled with and the cutting portion 220 and the support 230 is rotated in the drive shaft 240. When the cutting unit 220 and the support 230 is rotated, the linear motion shaft 250 which is connected to the support portion 230 at the distal side rotates. Also, the linear motion shaft 250 at a proximal side, because it is attached to the drive shaft 240 by connection 320, receives a rotational force from the proximal side. Thus, linear motion shaft 250 is likely to rotate following in time with respect to the drive shaft 240, it is possible to suppress the twisting of the linear shaft 250. Then, it is possible to suppress twisting of the linear motion shaft 250, it eliminates the need for work for twisting the linear motion shaft 250, effectively allows transmitting the driving force, it is possible to drive at a low torque. The connecting portion 320 for positioning outside the body during the procedure, even if by any chance damage, can ensure safety.

Drive shaft 240, because it is rotatably supported by the first bearing portion 331 and the second bearing portion 332, it can be smoothly rotated. Incidentally, within the first housing 351, the first seal portion 355 is in contact with the covering portion 242 provided on the outer peripheral surface of the drive shaft 240, by the drive shaft 240 is rotated, the coating unit 242 is first seal portion 355 slides against it, since the covering portion 242 is formed by low-friction material, rotation of the drive shaft 240 is not almost disturbed. Also, the linear motion shaft 250, because it is rotatably supported proximal portion by the third bearing portion 341 can be smoothly rotated.

Next, while rotating the cutting portion 220 and the support 230, as shown in FIG. 26 (B), it forces the treatment device 210. Accordingly, the convex portion 261 formed on the blade 47 and the tip tube 260 is formed in the cutting portion 220 (see FIG. 22) is in contact with the stenosis S, become debris D by constriction thereof is shaved It flows distally (downstream). Debris D flowing to the distal side, enters the inside of the filter portion 111 located at the distal side and is collected as taken strained by the filter unit 111. This can prevent the debris D flows into the peripheral, it is possible to suppress the generation of new stenosis in peripheral blood vessels.

Then, when cutting the stenosis S, the support portion 230, since the protruding radially outward between the struts 41, less support 230 effect on the living tissue in contact with the body tissue than the struts 41 Te, can suppress damage to the normal biological tissue by the edge of the strut 41, it is possible to improve safety.

Further, the cutting portion 220, a distal end portion 221 is not fixed to the support portion 230 and the linear motion shaft 250, at the beginning of the expansion, because of the extended by radially outward to receive the support 230, the struts 41 and a gap is hardly generated between the wire 231. Thus, hard hard debris D or stenosis prepared by dropping between struts 41 and the wire 231 is caught. Therefore, it does not increase the struts 41 turned up outward can suppress damage or breakage of the struts 41, and can suppress damage to the normal biological tissue by the edge of the strut 41.

When pushing the treatment device 210, after cutting the stenosis S is pushed cutting unit 220, before the cutting unit 220 has completely passed the stenosis S, it is possible to pull back the treatment device 210. Then, by repeating pushing and pulling back the treatment device 210, and gradually pushed cutting portion 220 with respect to stenosis S, the stenosis S can be cut little by little. Thus, excessive force to the cutting portion 220 is prevented from acting, it can suppress damage or breakage of the cutting unit 220.

When excessive cutting resistance in the cutting portion 220 (rotational direction resistance) acts, changes in current for driving the motor 96 occurs, a change in this current, the control unit 300 detects. Control unit 300 identifies the cutting resistance from the detected current, when exceeding a threshold which the cutting resistance is preset to stop the rotation of the motor 96. Then, the control unit 300 that the cutting resistance exceeds a threshold value, is displayed on the monitor 401, and notifies by sound by the speaker 402.

Also, excessive push-pull resistance to the cutting portion 220 (in the axial resistance) to act, is detected by the push-pull resistance measuring unit 310 is notified to the control unit 300. Control unit 300, if it exceeds a threshold pushing and pulling resistance is preset to stop the rotation of the motor 96. Then, the control unit 300 that the push and pull resistance exceeds a threshold value, is displayed on the monitor 401, and notifies by sound by the speaker 402.

When stopping the motor 96 upon detection of the cutting unit 220 excessive cutting resistance or push-pull resistance occurs, before damage or breakage occurs in the cutting section 220 can interrupt the cutting by the cutting unit 220. After the rotation of the motor 96 is stopped, as shown in FIG. 27 (A), pull back the treatment device 210, it is again rotate the motor 96 by operating the control unit 300, to be resumed cutting with treatment device 210 it can. The control unit 300, when the cutting resistance or push-pull resistance exceeds a threshold value, instead of stopping the rotation of the motor 96 may reduce the rotational speed. The control unit 300, without stopping the rotation of the motor 96 may only prompt the stopping of the motor 96 to the user by the notification unit 400.

As shown in FIG. 27 (B), after the cutting portion 220 has passed through the constricted portion S is pulled back treatment device 210, as shown in FIG. 28 (A), a cutting portion 220 proximate the stenosis S move to the side, to stop the rotation of the drive shaft 240. Then, by rotating the dial 360 again, as shown in FIG. 28 (B), further expanding the cutting unit 220. Then, similarly to the above-mentioned operation, the cutting portion 220 is rotated, while repeatedly pushing and pulling back the treatment device 210, while stopping the rotation by the control unit 300 when the cutting resistance and push-pull resistor exceeds a threshold value, Figure 29 (a), as shown in FIG. 29 (B), cutting the stenosis S little by little. After cutting portion 220 has passed through the constricted portion S is pulled back treatment device 210, the cutting portion 220 is moved proximally of the stenosis S, it stops the rotation of the drive shaft 240. Then, while gradually expanding the cutting unit 220, repeatedly pushing and pulling back the relative stenosis S of the cutting portion 220, cutting the stenosis S. Thus, while gradually expanding the cutting portion 220 by cutting the stenosis S, excessive force to the cutting portion 220 is prevented from acting, it can suppress damage or breakage of the cutting unit 220.

After cutting the stenosis S by the cutting portion 220 is completed, the dial 360 is rotated in the reverse rotation to the time obtained by extending the cutting portion 220 and the support 230. Thus, as shown in FIG. 16, the moving table 370 feed screw 361 rotates and moves distally, linear shaft 250 that is connected to the movable base 370 is moved distally. When the linear motion shaft 250 is moved distally, as shown in FIG. 15, the distal end portion 234 is moved away from the proximal side Teitan portion 235 of the support 230, the cutting section 220 and the support portion the state 230 is contracted radially inwardly. Then, moving distally the first housing 351 relative to the second housing 333, the outer sheath 270 is moved distally, as shown in FIG. 30 (A), cutting the outer sheath 270 parts 220 and the support portion 230 is accommodated. Thereafter, it is removing the treatment device 210 to the outside through the guiding catheter 140.

Thereafter, as shown in FIG. 30 (B), the sheath 120 is inserted into the blood vessel through the guiding catheter 140, After aspiration of debris D in the filter portion 111 in the sheath 120, the sheath 120, to accommodate the filter portion 111. Thereafter, the filter device 110 is withdrawn along with sheath 120, and removed the guiding catheter 140 and introducer sheath, the procedure is completed.

Then, during the procedure, the treatment device 210, since the storage bag 352 saline is constantly supplied, the outer sheath 270, the drive shaft 240, the inflow of blood into the linear motion shaft 250, and the inner tube 280 is suppressed, coagulation of blood in the treatment device 210 is suppressed. Therefore, it is possible to suppress a decrease in operability of the treatment device 210 by condensation of the blood, and condensed object can be suppressed from flowing into the vessel, safety is improved. Moreover, it can be suppressed from flowing out to the blood outside via the medical device 210, thereby improving the safety.

As described above, the medical device 200 according to the second embodiment, the drive shaft 240 is tubular body and is arranged inside the drive shaft 240 can move in the axial direction relative to the drive shaft 240 further includes a rotatable linear shaft 250 with the drive shaft 240 there is. The supporting portion 230 is extensible receives a force in the axial direction radially outward by the movement of the relative axial drive shaft 240 and the linear motion shaft 250, the struts 41, distally, drive not moved restraint in the axial direction with respect to the shaft 240 and the linear motion shaft 250, the struts 41 is pressed to expand radially outward by the expansion of the radially outer side of the support 230. Therefore, when expanding the strut 41, hardly a gap between the struts 41 and the support portion 230, comprising constricting substances and debris hardly caught between the struts 41 and the support portion 230. Therefore, the medical device 200 can suppress damage to the strut 41, and can suppress damage to the normal biological tissue by the edge of the strut 41.

The medical device 200 is a pipe body arranged inside the drive shaft 240, the rotation has further an inner tube 280 that is not constrained to the drive shaft 240 and the linear motion shaft 250. Therefore, the medical device 200 also drive shaft 240 and the linear motion shaft 250 rotates, the inner tube 280 does not rotate, the rotational force is not applied to the filter device 110 and guide wire that is inserted into the inner tube 280. For example, when the tube to insert the filter device 110 and guide wire directly to rotate, or worn by the inner wall surface and the sliding of the filter device 110 and guide wire tube, the filter device 110 and guide wire is rotated vent there is a case to be hard. In contrast, the medical device 200, the inner tube 280 does not rotate, it is possible to insert the filter device 110 and guide wire, to suppress the filter device 110 and guide wire wear, and the filter device 110 and guide wire is rotated that becomes difficult to disconnect can be suppressed. Further, when the tube is rotated, it becomes easy draws fluid such as blood therein, since the inner tube 280 does not rotate, the blood is not easily drawn into the lumen 281 of inner tube 280, the blood within the lumen 281 the generation of condensed deterrence, and can suppress a decrease in operability. Also, when the pipe a filter device 110 and guide wire or the like is inserted is rotated, allows the filter device 110 and guide wire or the like is moved in the axial direction, possibly damaging the blood vessels by the friction between the inner wall surface of the tubular body sex occurs. However, the medical device 200, since the inner pipe 280 filters the instrument 110 and guide wire or the like is inserted does not rotate, it is possible to suppress the damage to the vessel due to the filter device 110 and guide wire or the like is moved in the axial direction.

The medical device 200, a portion of the struts 41 or support 230, because it has a contrast portion consisting of X-ray contrast material, the location and expanded diameter of the struts 41 or support 230 accurately under X-ray fluoroscopy it is possible to grasp, the procedure is made more easily.

The medical device 200, cutting the distal side of the strut, to further having a tip tube 260 having a plurality of protrusions 261 are formed on the outer circumferential surface a tubular, the stenosis S by the tip tube 260 possible and it can be quickly cut a stenosis S.

The present invention also provides a method treating for cutting an object body lumen (treatment method). The method of treatment, a rotatable drive shaft is rotatable coupled to a distal side of the drive shaft, extensible along the rotation axis radially outward by the central portion is deflected with extending at least one strut is rotatable by being driven by the drive shaft, at least a portion is formed on the net and the tubular comprises a plurality of gaps positioned radially inwardly of said struts, and the rotary shaft a support portion is expandable radially outwardly by the central part of the direction is bent along the carried out using a medical device having a. Then, the treatment method includes the steps of inserting into a body lumen in a state of being contracted the strut and the support part (i), detecting the size of the gap of an object (ii) a body lumen the constriction is rotated by (iii) the struts and the steps to greatly expand than the support portion gap of the constriction at the proximal side of the narrowed portion, (iv) the drive shaft of the strut and the support portion a step of cutting the object of the constriction pushed into the gap parts, (v) a step of contracting the strut and the support portion, and a step of removing the said strut and the support part (vi) from a body lumen a. Treatment method configured as described above, since the strut and the support portion after than stenosis is expanded to a larger appropriate size than the gap of the constriction at the proximal side, it cutting an object of stenosis, stricture it is possible to effectively cut the object parts. Note that the constriction is meant to include an occlusion, occlusion is a form of constriction.

Further, the method of treatment described above, the step of cutting the object of the struts and step to the support portion extended and the constriction may be repeated at least once while gradually greatly extend the strut and the support portion. This can cut the object constriction gradually, while to reduce the load acting on the strut to suppress damage or breakage of the strut, can be more reliably cut the object.

Further, the method of treatment described above, in the step of expanding the strut and the support portion, the strut and the support part, may be extended to smaller size than the maximum expanded state. For example, when expanding the stenosis with a balloon, the balloon is dilate the stenosis by the maximum expanded state is set in advance, in the present treatment methods, the object of the constriction in the small state of the strut than the maximum expanded state You can cut, it is easy to set to the desired cutting conditions.

Further, the method of treatment described above, in the step of detecting the size of the gap of the constriction, to observe the imaging unit consisting of X-ray contrast material is provided in a portion of the strut or support section under X-ray fluoroscopy it is, may detect the size of the gap. Thus, the position and expanded diameter of strut or support unit, in comparison with the clearance of the narrowed portion under X-ray fluoroscopy it is possible to adjust precisely, the procedure is made more easily.

The present invention also provides other treatment methods for cutting an object body lumen (treatment method). The method of treatment, a tubular drive shaft be rotatable, and the outer sheath of the receiving tubular said drive shaft is rotatable coupled to a distal side of the drive shaft, along the axis of rotation by moving at least one strut can be extended radially outward by the central portion is deflected with extending, relatively in axial direction with respect to the drive shaft is arranged inside the drive shaft use the linear shaft for expanding the struts, between the outer sheath and the drive shaft, and a liquid supply portion for supplying liquid to at least one of between said drive shaft and linear motion shaft, the medical device having, (i) and inserting into a body lumen in a state where the strut deflated, the scan is moved relative to said drive shaft and (ii) the linear shaft A step of expanding the rat, comprising the steps of: (iii) the strut is rotated by the drive shaft for cutting the object of the body lumen, in a state where the insertion of the medical device (iv) in the body lumen, and supplying the liquid by the liquid supply unit to flow distally at least one between said between outer sheath and the drive shaft, and said drive shaft and linear motion shaft, contract the (v) said strut It has a step of removal from the body lumen, the Te. Treatment method configured as described above, between the outer sheath and the drive shaft, and since the liquid in at least one of between the drive shaft and linear motion shaft flows distally, while blood of the outer sheath and the drive shaft, and less likely to flow into at least one of between the drive shaft and linear motion shaft. Therefore, to suppress the coagulation of blood within the treatment device, and properly maintain the relative movement between the tube, it is possible to suppress the deterioration of the operability. Further, since it inhibited the outflow of blood through the medical device, safety is improved.

The present invention also provides a further treatment methods for cutting an object body lumen (treatment method). The method of treatment, a rotatable drive shaft is rotatable coupled to a distal side of the drive shaft, extensible along the rotation axis radially outward by the central portion is deflected with extending at least one strut is rotatable by being driven by the drive shaft, at least a portion is formed on the net and the tubular comprises a plurality of gaps positioned radially inwardly of said struts, and the rotary shaft has a support part is expandable directions by the central portion is deflected radially outward of, and a detector for detecting the resistance including at least one rotational direction resistance and axial resistance acting on the strut along the It is performed using a medical device. Then, the treatment method includes the steps of inserting into a body lumen in a state of being contracted the strut and the support part (i), the steps of expanding the (ii) the strut and the support portion, (iii) said strut a step of gradually cutting pushing and pulling back the object while repeatedly and the support portion relative to the object of the rotate the body lumen by the drive shaft, and a step of detecting the resistance by the detecting section (iv) , (v) the steps which resistance is notified that exceeds the stop or threshold rotation of the strut and the support portion when exceeding a preset threshold, to contract the strut and the support part (vi) biological has a step of removal from the lumen, the. Treatment method configured as described above, when said resistance exceeds a preset threshold, stopping the rotation of the strut and the support part, or to notify that the threshold is exceeded, excessive resistance acts on the strut when, it is possible to perform the addressing for suppressing damage or breaking of the struts, safety is improved.

Further, the method of treatment described above, after the step of notifying that the stop or the resistance to rotation of the strut and the support portion exceeds the threshold value, the step of moving the strut and the support portion contracts or along the axial direction it may further have. Thus, when resuming the cutting with struts again, resistance acting on the strut can be reduced, thereby suppressing the damage or breakage of the strut.

Further, the method of treatment described above, in the step of moving said strut and a support portion along the diameter or axial direction, the strut and the support part may be moved away from the object is moved in the proximal direction. Thus, when resuming the cutting, the strut and the support portion can be pushed against the object from the proximal side, it cut the object effectively.

The present invention is not limited only to the embodiments described above, various modifications are possible by those skilled in the art within the technical idea of ​​the present invention. For example, in the first embodiment, only the blade 47 on the distal side of the strut 41 is formed, may be formed on the proximal side of the strut, is formed on both the distal and proximal it may be.

In the first embodiment, a plurality of openings 45 on one of the struts 41 are formed, as shown in FIG. 31, the one strut 160, a long opening in the extending direction of the struts 160 161 there is only one form, the inner edge of the opening 161 may be a blade. Note that the portion having the same function as the previous embodiments are denoted by the same reference numerals, and description thereof is omitted.

In the first embodiment, although the inner edge of the opening 45 of the strut 41 is in the blade 47, the outer edge of the strut may be a blade.

The biological lumen medical device 10 is inserted is not limited to a blood vessel, for example, vascular, ureteral, biliary, fallopian tubes, may be hepatic duct or the like.

At least one of the cutting portion 40 and the support portion 50, as in another modification of the first embodiment shown in FIG. 32, may be coated with a coating layer 170 made of a hydrophilic material. In this way, between at least one and the living tissue of the cutting portion 40 and the support portion 50 is slippery, it is possible to improve safety by suppressing damage to normal biological tissue. Note that the portion having the same function as the previous embodiments are denoted by the same reference numerals, and description thereof is omitted.

Examples of the hydrophilic material include cellulose polymer materials, polyethylene oxide polymer materials, maleic acid polymer substance anhydride (e.g., methyl vinyl ether - maleic anhydride copolymers such as maleic anhydride copolymer) , acrylamide polymer materials (e.g., polyacrylamide, polyglycidyl methacrylate - block copolymers of dimethylacrylamide (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinyl pyrrolidone, and the like.

Also, the blade which is formed in the strut may be a polishing material such as diamond particles are attached to the outer surface of the strut.

In the first embodiment, radially inward of the struts 41, but the support portion 50 is disposed, a portion of the wire constituting the support portion may be disposed on the outside of the strut. With such a configuration, covering the sites that are not desired to be contacted with the living tissue of the strut wires, it is possible to reduce the damage of normal body tissue.

In the first embodiment described above, the cutting portion 40 and the support portion 50 can be extended to any size by operating the operation unit 90 may not be extended to any size. Further, the cutting portion and the support portion may have a structure that extends by self-restoring force.

In the first embodiment described above, the support unit 50 has been formed by braiding a plurality of wires 51, it is formed so as to mesh with a plurality of openings in one member good.

In the first embodiment described above, in order to move the linear shaft 70, but using the feed screw mechanism, to move the linear shaft 70, if possible, the structure is not limited.

In the first embodiment described above, to rotate the drive shaft 60, but using the motor 96, the drive source is not limited, be a gas turbine which is rotated by the high pressure gas such as nitrogen gas or the like good.

Further, at least a portion of the cutting portion and the support portion may be formed contains X-ray contrast material in the material. Thus, it is possible to accurately grasp the position under the X-ray contrast media, the procedure is made more easily. The X-ray contrast material, for example, gold, platinum, platinum - iridium alloy, silver, stainless steel, molybdenum, tungsten, tantalum, palladium, or an alloy thereof and the like.

Further, modification of the second embodiment shown in FIG. 33, the distal end portion 411 of the cutting portion 410 is fixed to the distal end 234 of the support 230, the proximal end 412 of the cutting portion 410 not fixed to the proximal end portion 235 and the drive shaft 240 of the support 230. Thus, the proximal end 412 of the cutting unit 410 relative to the proximal end 235 and the drive shaft 240 of the support 230, are relatively movable in the axial direction. Incidentally, the proximal end 235 of the support 230 is fixed to the drive shaft 240, distal end 234 of the support 230 is fixed to the linear motion shaft 250. Even in such a configuration, by bringing the distal end 234 and a proximal end portion 235 of the support 230, the shaft between the distal end 411 and a proximal fixed end 412 of the cutting portion 410 without a force in the direction, only force in the radially outward for receiving the support 230, it is possible to expand the struts 41 of the cutting unit 410. Note that the portion having the same function as the previous embodiments are denoted by the same reference numerals, and description thereof is omitted.

Also, as another modification of the second embodiment shown in FIG. 34, stretchable connection part 420 for connecting the proximal portion of the proximal portion and the driver shaft 240 of the linear motion shaft 250 is formed in a bellows it may be. Connecting portion 420, expansion in the axial direction becomes easier by a bellows. Note that the portion having the same function as the previous embodiments are denoted by the same reference numerals, and description thereof is omitted.

Also, as another modification of the second embodiment shown in FIG. 35, the outer sheath 270 is not connected to the first housing 431 of the liquid supply unit 430, the port portion 357 provided on the first housing 431 the distal end side of the third seal portion 432 may be provided. Then, the drive shaft 440, between the first seal portion 355 and the third seal portion 432, the hole 441 is formed. The outer surface of the drive shaft 440, the third seal portion 432 and slidably contact the second covering portion 442 for reducing the frictional force is covered. With such a configuration, between the outer sheath 270 and drive shaft 440, without supplying saline from storage bag 352, through a hole 441, between the drive shaft 440 and the linear motion shaft 250 it can be made to flow into the saline. Saline flowing into the drive shaft 440 can be flowed into the linear motion shaft 250 through the holes 251 of the linear motion shaft 250. Saline flowing into the linear motion shaft 250 can be flowed into the lumen 281 of the inner tube 280 through the holes 282 of the inner tube 280. Note that the portion having the same function as the previous embodiments are denoted by the same reference numerals, and description thereof is omitted.

Furthermore, the present application is based on Japanese Patent Application No. 2014-224105, filed November 4, 2014, the disclosures are referenced as a whole, it is incorporated.

10,200 medical devices,
20,210 treatment device,
30 filter device,
40,220 cutting part,
41,160 strut,
44 the inclined portion,
45,161 openings,
46 wide portion,
47 blade,
50,230 support portion,
51,231 wire material,
52,232 gap,
53 maximum extension,
60,240 drive shaft,
70,250 linear shaft,
75,260 tip tube,
80,270 outer sheath,
90,290 operation unit,
110 filter equipment,
111 filter unit,
120 sheath,
170 coating layers,
261 convex portion,
280 inner tube,
300 control unit (detection unit),
310 resistance measuring unit (detection unit),
320,400 coupling portion,
350,430 liquid feeding section,
D debris,
S constriction (object).

Claims (12)

  1. A medical device for cutting an object of a living body lumen,
    A rotatable drive shaft,
    Rotatable coupled to a distal side of the drive shaft, and at least one strut can be extended radially outward by the central portion is deflected with extending along the rotation axis,
    Rotatable coupled to a distal side of the drive shaft, at least a portion is formed on the net and the tubular comprises a plurality of gaps positioned radially inwardly of said struts, and the direction of along the rotation axis a support portion is extensible in the central portion is deflected radially outward, a medical device having a.
  2. The struts, medical device of claim 1 wherein the blade for cutting the object at the position of the distal side of the portion that most extended radially outward in the expanded state is formed.
  3. The maximum extension of the most extended radially outward of the supporting portion, the medical device according to claim 1 or 2 projects from between the struts radially outward than the struts in the expanded state.
  4. The struts, the outer peripheral surface of the site where the blade is formed, medical device according to any one of claims 1 to 3 is inclined as the rotation direction radially inward in the expanded state.
  5. The strut has a relatively wide wide portion than to the region where the width in the rotation direction are adjacent, medical according to any one of claims 1 to 4, wherein the blade on the wide portion is formed device.
  6. Length maximum extension protrudes from the strut radially outward, the support portion from between said struts at a site where the wide part is arranged diameter of the most expanded radially outward of the supporting portion in the expanded state the medical device of claim 5 greater than the length which projects outwardly.
  7. The struts, medical device according to any one of claims 1 to 6 having an inclined portion inclined with respect to the rotary shaft in contracted state.
  8. The struts and at least one of the support portions, medical device according to any one of claims 1 to 7 is coated with a hydrophilic material.
  9. Wherein the drive shaft is a tube body,
    Is movable relatively in axial direction with respect to the drive shaft is arranged inside the drive shaft, and further comprising a rotatable linear shaft with said drive shaft,
    The support portion is extensible radially outwardly receives a force in the axial direction by the movement of the relative axial of the drive shaft and linear motion shaft,
    The struts, distal or proximal side, moved in the axial direction is not constrained to the drive shaft and linear motion shaft, the strut is pressed by expansion of the radially outer side of the supporting part medical device according to any one of claims 1 to 8, extend radially outward.
  10. Wherein the drive shaft is a tube body,
    Is movable relatively in axial direction with respect to the drive shaft is arranged inside the drive shaft, and a linear shaft rotatable with said drive shaft,
    A tubular body which is arranged inside the drive shaft, the medical device according to any one of claims 1 to 9, further having an inner tube that rotates is not constrained to the drive shaft and linear motion shaft .
  11. The struts or a part of the support portion, the medical device according to any one of claims 1 to 10 having an imaging unit consisting of X-ray contrast material.
  12. The distal side of the strut, a plurality of convex portions are formed on the outer circumferential surface a tubular, and according to any one of claims 1 to 11, further having a rotatable tip the tube together with the drive shaft medical device.
PCT/JP2015/065888 2014-11-04 2015-06-02 Medical device WO2016072107A1 (en)

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JP2014224105 2014-11-04
JP2014-224105 2014-11-04
US201562104487 true 2015-01-16 2015-01-16
US62/104487 2015-01-16

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US15586844 US20170258488A1 (en) 2014-11-04 2017-05-04 Medical device

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US20160120570A1 (en) 2016-05-05 application
JPWO2016072107A1 (en) 2017-08-10 application
US20170258488A1 (en) 2017-09-14 application
US20160120569A1 (en) 2016-05-05 application
US20160120568A1 (en) 2016-05-05 application
US20160120565A1 (en) 2016-05-05 application

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